Process Expert

Role Summary

The Process Expert provides front-line support for manufacturing process issues, driving quality and efficiency improvements in compliance with cGMPs, SOPs and applicable guidelines and normatives. This role is on-site in Morris Plains, NJ, on the first shift with no relocation assistance, and may require working Sunday through Wednesday or Wednesday through Saturday. The position focuses on supporting cell processing manufacturing, ensuring each batch is produced safely, on time, and in accordance with batch records and quality requirements. The Process Expert collaborates with cross-functional teams to identify deviations, CAPAs, and opportunities for process improvement.

Responsibilities

• Provide front line technical and procedural support to manufacturing, working with the cell processing team, focusing on manufacturing each batch safely, on time, in compliance with the batch record and quality requirements.
• Provides latest information regarding best practices, investigation findings, CAPAs, MST/TRD experiences to manufacturing SMEs.
• Perform data analysis and identifies potential process shifts/trends and escalate as necessary.
• Author investigations for product and non-product deviations.
• Conduct manufacturing investigations for Out Of Expectation (OOE), Out Of Specification (OOS), Out of Tolerance (OOT) results.
• Work cross-functionally to assess deviation impact and identify root causes.
• Work with Scheduling and QA to ensure that batches are released on time through the closure of robust investigations and impact/risk assessments.
• Use process knowledge and root cause investigation tools to analyze data and to identify and root causes of product and process failures.
• Initiate CAPAs and CAPA effectiveness checks to eliminate/mitigate deviations.
• Support the process of escalation of deviations when appropriate according to escalation guidelines. Present escalation events and provide deviations details clearly and on-time (root cause and CAPAs).
• Identifies opportunities for process, operational, and quality improvements in conjunction with Manufacturing Team (PU) and Operational Excellence Team (OpEx).
• Execute process technical batches to generate sufficient process knowledge by thoroughly testing critical variables.
• Evaluates manufacturing pre-production technical planning, review of technical data of incoming apheresis materials, to ensure timely and required batch pathway processing by the manufacturing team.
• Provide timely updates to management on status of manufacturing performance. Escalate potential performance issues to 3rd parties.
• Provide timely support for process technology transfer activities from clients/3rd parties.
• Develop and provide training (as immediate response to unexpected events, for technical document execution, and new products/processes) to the Cell Processing team, as required.
• Owns the Training Curriculum for this Job Profile and provides the necessary training and support to new associates joining the Process Expert position.
• Coach new investigators as part of the Investigator Certification Program.
• Maintain their processes at inspection readiness level and provide the necessary support in any internal or external audit.
• Authorities' inspections

Qualifications

• Bachelor's degree in Science, Engineering or Biology or related field is required
• 3+ years of relevant experience in pharmaceutical industry is required.
• Previous GxP experience is required.
• Excellent communication and collaboration skills.